The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes

Launched by THE UNIVERSITY OF NEW SOUTH WALES · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how a 0.1% version of an eye drop called ciclosporin A affects immune cells on the surface of the eye in people with dry eye disease (DED). DED is a common condition that causes discomfort due to issues with tear production or quality. The trial will compare the effects of ciclosporin A to regular lubricating eye drops to see how they influence the immune response in the eye, which is important for understanding and improving treatment options for DED.

To participate in the trial, individuals need to be at least 18 years old and meet specific criteria for DED, such as a certain score related to eye discomfort and tear levels. However, people who have used certain eye medications recently, have specific eye conditions, or are pregnant or breastfeeding may not be eligible. Participants will undergo testing using a special technique to observe their eye's immune cells over 12 weeks, helping researchers learn more about how ciclosporin A works in treating DED.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years of age and above
• • 2. Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score of ≥1 iii) Tear meniscus height \< 0.2 mm.
• Exclusion Criteria:
• • 1. Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.
• • 2. Participants with systemic CsA or tacrolimus
• • 3. Known hypersensitivity or contraindication to the study medication or any of its ingredients.
• • 4. Active intraocular inflammation.
• • 5. Contact lens wear or the use of contact lenses in the last 4 weeks.
• • 6. Active eye infections or history of critical illness.
• • 7. DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.
• • 8. Participants with other ocular co-morbidities and medications for glaucoma.
• • 9. Participants with previous history of ocular surgery in the past 6 months.
• • 10. Any other active or inactive systemic condition, structural abnormality such as eyelid malposition's that in the judgment of the investigator could confound study assessments or limit compliance.
• • 11. Pregnant/breastfeeding women